Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Recruiting PHASE3 INTERVENTIONAL NCT06513962

Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Detailed Description

PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age \< 40 years (exclusive of breast cancer). II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients. SECONDARY OBJECTIVES: I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients. II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients. EXPLORATORY OBJECTIVE: I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 and 2 years.

Interventions

Name: Best Practice
Type: OTHER
Description: Receive standard chemotherapy
Name: Biospecimen Collection
Type: PROCEDURE
Description: Undergo blood sample collection
Name: Electronic Health Record Review
Type: OTHER
Description: Ancillary studies
Name: Survey Administration
Type: OTHER
Description: Ancillary studies
Name: Triptorelin Pamoate
Type: DRUG
Description: Given IM

Primary Outcomes

Measure: Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years
TimeFrame: Up to 2 years post-chemotherapy
Description: Number of enrollments by the end of the DOD funded grant period, and ideally prior to Year 4 to enable greater duration of follow-up time. Will help determine if a larger efficacy study can be successfully completed as a cross network trial in a reasonable funding period.
Measure: Accrual rates of newly diagnosed AYA female cancer patients age < 40 years
TimeFrame: Up to 2 years post-chemotherapy
Description: Accrual rates of newly diagnosed AYA female cancer patients age \< 40 years. Over the second half of the funding period, demonstrate a positive trajectory in accrual rates that provides data to inform future funding proposals that would seek to complete the overall larger study within a typical 5-year funding period.
Measure: Anti-mullerian hormone (AMH) levels
TimeFrame: At 2 years post-chemotherapy
Description: AMH values will be examined to confirm that the combined variability of AMH in both arms is consistent with our a priori assumptions.

Trial Information

NCT ID

NCT06513962

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Children's Oncology Group

Last Updated

December 15, 2025